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Is advisory notice applicable to a subcontract manufacturer ?

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Guest user Created:   Apr 15, 2019 Last commented:   Apr 15, 2019

Is advisory notice applicable to a subcontract manufacturer ?

Does Advisory Notice is applicable for the organization that produce product for other company (sub contract). should we create a procedure regarding this? Our organization not supply to end customer, but delivered to Main company first.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Apr 15, 2019

Answer:

Even though your company might not be the product owner, Advisory Notice is still applicable for your organization as a manufacturer of the device.
For example, in the situation where there is some field safety corrective action, you might be required to take part in the investigation and hence it is recommended for you to have a procedure for this in order to be compliant with ISO 13485 and local regulatory requirements in your country.

For more information, you might refer to:

How to manage recalls and advisory notices for medical devices according to ISO 13485

https://advisera.com/13485academy/blog/2017/08/31/how-to-manage-recalls-and-advisory-notices-for-medical-devices-according-to-iso-13485/
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Apr 15, 2019

Apr 15, 2019

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